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This was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized, placebo-controlled study (NCT00053560. Bone Mineral Density assessments were performed at baseline and at months 6 and 12.

A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study.

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Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01.

Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.

Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.

Exclusion Criteria:

Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.

Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).

MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY

Calcitonin

Bisphosphonates

Fluoride at pharmacologic dose

Strontium at pharmacologic dose

Estrogenic steroids (except oral contraceptives)

Selective Estrogen Receptor Modulator (raloxifene)

Parathyroid hormone

Any androgens, including prescription or nutritional supplement DHEA, other than study drug

Additional Calcium supplements other than those prescribed as part of this study